Presentation Authors: Irwin Goldstein*, Sue Goldstein, Noel Kim, San Diego, CA, Susan Kellogg Spadt, Rosemont, PA, Filippo Murina, Milan, Italy
Introduction: CO2 fractional laser (MonaLisa Touch) for treatment of vestibulodynia via a vestibular probe has been found clinically useful in a pilot study. A 3-site, prospective, double-blind, sham-controlled investigator-initiated research study was performed to further examine the safety and efficacy of CO2 fractional laser delivery in women with vestibulodynia.
Methods: Subjects meeting inclusion and exclusion criteria were randomized to active or sham treatment 2:1. Changes were assessed on multiple outcome measures, including cotton swab test at 1:00, 3:00, 5:00, 6:00, 7:00, 9:00 and 11:00 positions, Female Sexual Function Index (FSFI) pain domain and total score, Female Sexual Distress Score (FSDS-R), and O&[prime]Leary/Sant Voiding and Pain Indices (ICSI/ICPI). Each arm consisted of 3 treatments 4 weeks apart (weeks 0 â€“ 8). Follow-up visits were completed at weeks 12 and 16. Subjects assigned to sham were crossed over to active treatment at 12 weeks, administered 3 active treatment sessions with additional follow-up.
Results: This is an interim analysis of the first 53 subjects. Cotton swab test scores in subjects assigned to active treatment decreased at visits 3-6, whereas no laser therapy (sham arm) resulted in minimal changes. Change from baseline in cotton swab test scores was significantly reduced after active treatment at week 12 (mean = 1.05; 95% CI [-1.21, -0.89]) and at week 16 (mean = -1.20; 95% CI [-1.36, -1.04]), suggesting decreased pain. FSFI pain domain scores (change from baseline) increased significantly at week 12 (mean = 1.13; 95% CI [0.45, 1.81]) and week 16 (mean = 1.45; 95% CI [0.76, 2.13]), indicating improved function. FSFI total scores (change from baseline) increased significantly at weeks 12 and 16 (mean = 4.72; 95% CI [2.05, 7.40] at both times). Distress related to vestibulodynia (change from baseline in FSDS-R scores) decreased significantly at weeks 12 and 16 (mean = -5.98; 95% CI [-9.23, -2.73] and -8.42; 95% CI [-11.67, -5.16], respectively). ICSI scores (change from baseline) decreased significantly at weeks 12 and 16 (mean = -0.79; 95% CI [-1.35, -0.24] and -1.23; 95% CI [ 1.78, -0.67], respectively). ICPI scores (change from baseline) decreased significantly at weeks 12 and 16 (mean = -0.70; 95% CI [-1.38, -0.02] and -1.26; 95% CI [-1.94, -0.59], respectively). No SAEs occurred.
Conclusions: These data from an interim exploratory analysis suggest that CO2 fractional laser therapy in women with vestibulodynia improves subjective measures of pain and pain related to sexual activity, and also decreases pain symptoms and bother related to bladder voiding.